BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS

    K Number: K020364 · Decision Jun 4, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    161
    Applicant Total
    21
    Review Days
    120

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    Basic Information

    Device Name
    PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS
    K Number
    K020364
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1665
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Phoenix Diagnostics, Inc.
    Date Received
    February 4, 2002
    Decision Date
    June 4, 2002
    Product Code
    JGS
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JGS Electrode, Ion Specific, Sodium

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    Other Clearances by Phoenix Diagnostics, Inc.

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    K960592 ELECTROLYTE STANDARDS
    K945860 SPECTRUM CO-OXIMETER LINEARITY CONTROL
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